Additional Information
Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.
Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you're ready to join us at the edge of something unstoppable, let's make a profound impact together for our patients, for your career, for what's beyond .
You can view our latest corporate deck and other presentations here .
About the Role >>> Lead Senior Medical Writer
As the Lead Senior Medical Writer, reporting to the Director of Medical Writing, you will lead the development, and delivery of high-quality scientific and regulatory documents supporting Olema's oncology portfolio. This role requires strong cross-functional leadership, partnering closely with Clinical Science, Clinical Development, Regulatory Affairs, Biometrics, and other stakeholders to translate complex clinical and preclinical data into clear, accurate, and compelling content for regulatory submissions, medical communications, and scientific publications. In addition, you will drive consistency, quality, and timelines across deliverables, contributing to the overall medical writing strategy and supporting key regulatory and clinical milestones.
This role is based out of our Boston, MA or San Francisco, CA office and will require 10-15% travel .
Your work will primarily encompass:
Preparing and editing a wide range of scientific and medical writing deliverables, including but not limited to protocols, protocol amendments, clinical study protocols, investigator brochures, regulatory submission documents (e.g. IBs, DSURs, sections of IND/IMPD/MAAs), PowerPoint presentations related to the Medical Writing function
Collaborating with internal stakeholders (clinical scientists, regulatory strategy, medical monitors, biometrics, medical affairs) to understand data, interpret results, and ensure accurate message conveyance
Ensuring documents adhere to internal style guidelines, regulatory requirements (e.g., ICH, GPP), and appropriate therapeutic-area standards (e.g., oncology, breast cancer)
Maintaining version control, track author/reviewer feedback, and delivering documents according to project timelines
Providing writing and/or QC editing support for associated submission documents (as applicable) to help elevate overall team deliverables
Remaining current on therapeutic area (breast cancer / endocrine-driven tumors) trends, journal publications, and regulatory guidance relevant to oncology and women's cancers
Ideal Candidate Profile >>>
A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge , experience , and attributes for this role.
Knowledge:
Bachelor's degree in life sciences, pharmacy, or related field; advanced degree (MS/PharmD/PhD) preferred
Demonstrated and excellent scientific writing and editing skills - the ability to translate complex scientific data into clear, concise, accurate documents for varied audiences (regulatory agencies, KOLs, internal stakeholders)
Familiarity with regulatory writing standards (e.g., ICH E3/E6, GPP)
Oncology preferred
Veeva RIM experience is a plus
Olema · San Francisco, CA